Identity
- Trade Name
- DARCO® OrthoWedge™ healing shoe FDA UDI
- Generic Name
- Orthotic shoe, non-customized FDA UDI
- Device Name
- Extra-large Black Square-toe FDA UDI
- Model / Reference
- OQ4B FDA UDI
- Description
- Extra-large Black Square-toe FDA UDI
Identifiers
- Catalog Number
- OQ4B; OW4B-ST FDA UDI
- Primary DI / UDI-DI
- 00609271819450 FDA UDI
- FDA Product Code
- KNP FDA UDI
- GMDN Term
- Orthotic shoe, non-customized FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthotic shoe, non-customized
DARCO® OrthoWedge™ healing shoe by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic shoe, non-customized.
- VIVE — VIVE HEALTH LLC · Class I
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- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® Relief Dual® Plus — Darco (Europe) GmbH · Class I
- DARCO® WCS™ — Darco (Europe) GmbH · Class I
- Position Health® Classic Post-Op Shoe — Walgreen Health Solutions, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DARCO International, Inc.
Sources (1)
- FDA UDI fabc2f6b-90da-4b86-adc4-2a580938705e 34 fields · synced Jun 9, 2026